EXTRA STRENGTH BALM- capsicum, menthol ointment

Extra Strength Balm by

Drug Labeling and Warnings

Extra Strength Balm by is a Otc medication manufactured, distributed, or labeled by NATURES FORMULAE HEALTH PRODUCTS LTD., Natures Formulae Health Products Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Capsicum (from Capsicum Frutescens fruit extract) 5%

Menthol 2.5%

Purpose

Topical Analgesic (Counterirritant)

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains. Provides warming pain relief.

Warnings

For external use only.

Avoid contact with the eyes

Do not use while pregnant or breastfeeding.

Do not apply to wounds damaged skin bandage tightly with external heat. This may result in skin irritation or skin burn.

Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days clear up and reoccur within a few days.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply a thin layer to affected area not more than 3-4 times daily, massaging well into skin. Wash hands well after use. Patch test recommended prior to use. Spatula recommended to reduce contact with the product. Do not inhale directly–keep lid on product when not in use.

Other Information

Store in a cool, dry place.

Inactive Ingredients

Beeswax, butyrospermum parkii (shea) butter, calendula officinalis flower extract, capryloyl glycerin, cinnamomum zeylanicum (cinnamon) leaf oil, cocos nucifera (coconut) oil, diheptyl succinate, elettaria cardamomum (cardamom) seed oil, eugenia caryophyllus (clove) bud oil, glycine soja (soybean) oil, olea europaea (olive) fruit oil, prunus amygdalus dulcis (sweet almond) oil, rosmarinus officinalis (rosemary) extract, rosmarinus officinalis (rosemary) leaf oil, rubus idaeus (raspberry) seed oil, sebacic acid copolymer, simmondsia chinensis (jojoba) seed oil, squalane, theobroma cacao (cocoa) seed butter, tocopherol, zingiber officinale (ginger) root oil

PRINCIPAL DISPLAY PANEL

Saje

Natural Wellness

Extra Strength Balm

Warming pain relief ointment

net wt 25 g | 0.9 fl oz

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH BALM 
capsicum, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69204-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ELETTARIA CARDAMOMUM SEED OIL (UNII: JM0KJ091HZ)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL (UNII: 8LGU7VM393)
SQUALANE (UNII: GW89575KF9)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
RUBUS IDAEUS (RASPBERRY) SEED OIL (UNII: 9S8867952A)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
EUGENIA CARYOPHYLLUS (CLOVE) BUD OIL (UNII: 578389D6D0)
ROSEMARY (UNII: IJ67X351P9)
HYDROGENATED CASTOR OIL/SEBACIC ACID COPOLYMER (UNII: H7DBQ4WF5M)
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)
CINNAMOMUM ZEYLANICUM LEAF OIL (UNII: S92U8SQ71V)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
BEESWAX (UNII: 2ZA36H0S2V)
BRASSICA CAMPESTRIS (RAPESEED) SEED OIL (UNII: N4G8379626)
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL (UNII: 66YXD4DKO9)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69204-030-01	1 in 1 CARTON	01/01/2026
1		25 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2026

Labeler - NATURES FORMULAE HEALTH PRODUCTS LTD. (241385587)

Establishment
Name	Address	ID/FEI	Business Operations
Natures Formulae Health Products Ltd.		241385587	manufacture(69204-030)